Peripheral Arterial Disease, Antiplatelet Therapy Clinical Trial
Official title:
Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (ASPIRE PAD).
To evaluate whether clopidogrel 75 mg daily on a background of aspirin 75- 100 mg/d for 12 months or for 1 months will lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at 1 year
To evaluate whether clopidogrel 75 mg QD on a background of ASA 75-100 mg/d for 12 months or
for 1 month will lead to an increased rate of primary patency, limb salvage, freedom form
ischemic stroke and survival, in patients receiving endovascular treatment of PAD.
Trial hypothesis We hypothesize that DAPT with ASA and clopidogrel administered for 12
months following iliac, FP or BTK endovascular intervention will improve primary patency,
limb salvage, freedom form ischemic stroke and survival, in patients with symptomatic PAD.
Trial endpoints Clinical endpoints will be analyzed in all subjects who are enrolled,
regardless of whether the trial treatment administered successfully completed for the
desired duration. A subject will be considered enrolled in the trial when he/she is
randomized to one of the treatment arms of the study. All endpoints are subject-based unless
otherwise specified.
The primary endpoint is a subject-based 12-month endpoint of the first occurrence of index
limb arterial occlusion, surgical intervention, endovascular intervention, amputation of the
affected limb (primary patency and limb salvage), MI, ischemic stroke or death (survival)
The secondary endpoints are subject-based 12-month endpoints that include: (a) the first
occurrence of any individual component of the primary endpoint, (b) the first occurrence of
the following during follow-up: cardiovascular death, or MI, or ischemic stroke, or any
amputation above the ankle and (c) severe bleeding defined according to the Global
Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries
(GUSTO)classification The tertiary endpoint is based on 12-month moderate bleeding according
to the GUSTO classification
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment